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NCT Number: NCT05301283

Habitat Escalated Adaptive Therapy (HEAT), With Neoadjuvant Radiation for Soft Tissue Sarcoma

The purpose of the study is to utilize radiomic images to precisely locate areas of tumor that can be treated with dose escalation radiation therapy.

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Key information

Conditions

High Grade Sarcoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Moffitt Cancer Center

Tampa, Florida, 33612, United States

Location status: Recruiting

Location contact

Arash O Naghavi, MD, MS

PRINCIPAL_INVESTIGATOR

Marilyn Bui, MD, PhD

SUB_INVESTIGATOR

Nainesh Parikh, MD, MBA

SUB_INVESTIGATOR

Ricardo Gonzalez, PhD

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Provision of signed and dated informed consent form
  • Stated willingness to comply with all study procedures and availability for the duration of the study
  • For women of childbearing potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation and for an additional 52 weeks after the end of radiation.
  • For males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner 52 weeks after radiation.
  • Agreement to adhere to Lifestyle Considerations (as outlined in protocol) throughout study duration.
  • Pathologically (histologically or cytologically) proven diagnosis of high-grade (grade 2 or 3) Soft Tissue Sarcoma (STS) of the deep trunk and/or extremity. Clinical evidence should be documented, and may consist of pathology or imaging, and should be sufficient to estimate the size of the primary (for T stage)
  • Primary site deemed resectable prior to the start of trial
  • American Joint Committee on Cancer (AJCC) 8th edition staging T1-4 N0 M0, no evidence of distant metastases
  • Patients must have clinically or radiographically evident measurable disease at the primary site.
  • Pre-Radiation Therapy (RT) MRI within 4 weeks of the start of RT.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status 0 to 3.
  • Deemed a surgical candidate
  • Participant agrees to blood and plasma preservation for future analysis.

Exclusion criteria

  • Contraindications to an MRI
  • Positive urine pregnancy test
  • Gross total excision of primary STS, including an unplanned excision
  • Superficial sarcoma located primarily in the subcutaneous or cutaneous tissue
  • Prior radiation to the region of the study cancer that would result in overlap of radiation therapy fields.
  • Participants with a medical condition or social situation that, at the discretion of the principal investigator, would preclude them from completion of the trial.

Treatment and study plan

Intensity Modulated Radiation Therapy (IMRT)

Radiation

Participants will be treated with intensity modulated radiation therapy (IMRT) with photons, which is FDA (U.S. Food and Drug Administration) approved radiation delivery system.

MRI

Diagnostic Test

Participants will receive pretreatment diagnostic MRIs to generate MRI habitats. These images will identify radioresistant cells within tumor.

Primary outcomes

  1. Rate of Favorable Pathologic Response (FPR)

    Time frame: Week 10

    Percentage of participants with Favorable Pathologic Response (FPR): tumor necrosis >/= 95% at time of surgery. FPR is associated with improved R0 resection rates, local control, distant control, and overall survival. Therefore, FPR acts as an early surrogate for outcome.

Secondary outcomes

  1. Percentage of tumor with clear margin and positive margin

    Time frame: Weeks 10-13

    Review of final tumor margin of the surgical specimen, defined as tumor at ink margin, will be conducted by pathologist. A clear margin (R0) or a positive margin (R1/R2) will be designated, along with the location of the margin, which will be radiographically correlated to the habitat . Surgical margins are independent predictors for local control.

Other outcomes

  1. Disease Control Rate

    Time frame: Up to 6 months

    Disease control rate defined as the sum of complete response, partial response, and stable disease rates.

  2. Overall Survival

    Time frame: Up to 8 months

    Overall Survival defined as the time from date of initial treatment to date of death.

Study contacts

Contact information is provided by the study sponsor or research team.

Inaya Lemus

CONTACT

[email protected]

813-745-4233

Sponsors and collaborators

Lead sponsor

H. Lee Moffitt Cancer Center and Research Institute

Other

Collaborators

  • Viewray Inc.

Registry information

Official study title

Phase 2 Clinical Trial of Radiomic Habitat-Directed Radiation Dose Escalation for High-Grade Soft Tissue Sarcoma

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Mar 29, 2022
Registry last updated
Dec 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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